从循证医学角度分析《中国新药与临床杂志》发表的临床试验文献

目的 :从《中国新药与临床杂志》2 0a来发表的文献鉴定出药品临床研究的类别并对其分析评价 ,以了解该杂志及我国新药与临床研究的水平。方法 :对《中国新药与临床杂志》创刊至 2 0 0 1年共2 0卷 116期采用手工检索逐期逐页鉴定 ,筛选新药临床试验文献并加以分析评价。结果 :2 0a间共发表 15 0 6篇临床研究文献。其中 ,随机对照试验(RCT) 5 71篇 (双盲RCT 70篇 ) ,占 37.92 %;临床对照试验 (CCT) 490篇 ,占 32 .5 4 %;无对照临床治疗研究 (Non CT) 445篇 ,占 2 9.5 4 %。按每 5a一个时段统计 ,RCT所占比例逐年增加 ,1982～ 1986年为 8.6%( 10 /116) ,1987～ 1991年为 2 2 .9%( 4 8/2 10 ) ,1992～ 1996年为 4 5 .9%( 2 0 3/44 2 ) ,1997～ 2 0 0 1年为 4 2 .0 %( 30 9/736)。结论 :《中国新药与临床杂志》所发表的药品临床研究文献具有较高水平 ,其中RCT和CCT文献所占比例呈逐年上升趋势。

Assessment of clinical trial literatures published in "Chinese Journal of New Drugs and Clinical Remedies"on evidence-based medicine

AIM: To identify the sorts of drug's clinical trial which were published in “Chinese Journal of New Drugs and Clinical Remedies” for 20 a, and assess the quality of them in order to understand the levels of this journal, of new drug and of clinical trials in China. METHODS: Hand searching was made to identify and select the literatures of clinical trail published in “Chinese Journal of New Drugs and Clinical Remedies” from Volume 1, No 1 to volume 20, No 6, total 116 according to the Cochrane Collaboration Handbook (1997), and make an assessment. RESULTS: There were totally 1 506 literatures during the 20 years, including 571 RCT (37.92 %), 490 CCT (32.54 %) and 445 Non-CT (29.54 %). The proportion of RCT in clinical trail was increasing steadily. The proportion was 8.6 % from 1982 to 1986 (10/ 116), 22.9 % from 1987 to 1991 (48/210), 45.9 % from 1992 to 1996 (203/ 442) and 42.0 % from 1997 to 2001 (309/ 736), respectively. CONCLUSION: The quality of the literatures for clinical trail published in “Chinese Journal of New Drug and Clinical Remedies” remains on a higher level. The proportion of RCT and CCT literatures in clinical trials is on upward trend. Multi-center and large-scale collaborative study is worthy to advocate.